Pioneering Ideas

Gaining Perspectives on mHealth

In my recent blog post summarizing December’s mHealth Summit, I began by saying that the mHealth organizers must have been pleased with the conference, given its growth in attendance and engagement.

We were equally pleased with RWJF and Pioneer’s presence at the meeting – in fact, I’d say the meeting was a resounding success from our perspective.

Pioneer grantees Ben Sawyer and Debra Lieberman were both on panels featuring their work in health games and mobile technology. Deborah Estrin and Ida Sim announced the launch of Open mHealth, which is supported with funding from RWJF’s Pioneer Portfolio. And a session focused on this summer's mHealth Evidence meeting that was conceived of and co-sponsored by Pioneer.

Our Public Health Portfolio was also there looking for interesting perspectives on how mHealth could be deployed by public health departments to address a variety of health issues.

And finally, I was lucky enough to moderate a special session on a topic of keen interest to me and the portfolio.

“What I Really Need from mHealth: Five Perspectives on Value” featured a great cast of panelists including Robert Jarrin, senior director of Government Affairs for Qualcomm; Carol McCall, chief strategy officer at GNS Healthcare; Anmol Madan, founder of Ginger.io and visiting researcher at MIT Media Lab; and Richard Katz, director of cardiology at George Washington University Hospital.

Our session was structured around an imaginary mobile health application. The panelists discussed the value  of the application and how to demonstrate that value from the point of view of the individual, provider, various payers, regulators and researchers. This generated a fascinating conversation in which participants spoke from both a professional and personal perspective. Toward the end, we opened the discussion up to the attendees, which led to an informative and engaging discussion that will hopefully extend far beyond the session. The various perspectives are not completely aligned but yield something quite important when they do come together.

But wait, as they say on TV, there’s more! In addition to our panelists, we brought together about a dozen thought leaders, including representatives from organizations like NIH, Google, GNS Healthcare and the National Science Foundation, for a series of lively discussions about the future of mHealth and how to build value for all the players in the ecosystem. There was no lack of good ideas or strongly held opinions, and more questions were raised than answers offered. However, at the end of the night, we could all see light at the end of the tunnel. And that light came from a greater understanding of the value others saw in mHealth. From this newly fashioned broader vision, I’m hopeful we all left with a better sense of the way forward and with new ideas on how we could each play a role. 

I look forward to sharing more of what we learned and what this might mean for our investments in mHealth moving forward – and hearing your thoughts as well.

Reflections from mHealth Summit 2011

I'm sure that the organizers of this year's mHealth Summit were more than pleased. There were more than 3,600 people in attendance, up 1,200 from last year. The exhibit floor was larger and more complex, rivaling some trade shows. There were tracks for business, research, policy and technology along with a slew of special sessions and keynotes from Secretary of Health & Human Services Kathleen Sebelius and Surgeon General Regina Benjamin, among others. Some presentations soared with whiz-bang demos and promises of how technology will change the world; others bemoaned the complexity of interoperability, the "silo-ization" and the lack of demonstrated value.

While there is no question that mHealth is on the rise, some, including myself, are wondering if we’re heading toward a bubble of inflated expectations. As with all bubbles—dot com, housing etc.—the question isn’t whether there is significant underlying value (there is), but instead “how do we invest in the value that can be realized without buying into overinflated hype?” In the context of the ‘90s’ dot-com bubble, “How do we place our bets on Google and not on pets.com?”

The answer isn’t going to be found in the next jazzy consumer-oriented gadget, but by connecting great ideas that will help us lead happier, healthier lives over the long haul – connecting business, research, technology, and policy interests to find shared value.

I came away from the 2011 mHealth Summit optimistic in the overall potential of mHealth, but a little skeptical about the direction it seems to be heading in. Introducing multiple new and evolving health innovations is inherently complex, as is the perversity of our current health infrastructure. Yet one can’t help but notice that there are some very smart people working on developing the promise mHealth can offer to address some of our most pressing health challenges.

A central question will be how willing those from the “m” will be to ensure that the “health” is improved? And how open will the folks from “health” be in fulfilling the promise of “m” technology?

This will require us all to see value from others’ perspectives in this growing ecosystem. I’ll explore this more in my next blog post, so stay tuned.

In the meantime, take a moment to peruse RWJF’s coverage of the Summit on NewPublic Health.org, which tapped into some of the conversations, new collaborations and innovations in mobile health that might feasibly be applied to public health, and started a conversation about the potential for mobile technologies to help the public health field connect with hard-to-reach populations and bridge disparities.  Read what they learned in interviews with Susannah Fox of the Pew Internet and American Life Project about advances in mHealth, with Yvonne Hunt of the National Cancer Institute about the potential for mHealth in public health, and with Robert Kaplan, director of the Office of Behavioral and Social Sciences at the National Institutes of Health about the rigorous research still needed to support the field. We’d love to know what you think, so don’t forget to comment on each post or below to share your insights.

What Do We Really Need from mHealth?

The December 5-7 mHealth Summit is approaching and I’m pleased and excited to be moderating the special session: What I Really Need from mHealth: Five Perspectives on Value.

Pioneer has been involved with multiple aspects of mHealth since very early on and has seen interest grow into what sometimes seems to me to be an “irrational exuberance,” to borrow a phrase from Alan Greenspan. I’m concerned that we’re on the way to another bubble that’s in danger of bursting with unfortunate consequences. The fact is we often don’t know what “works,” and even what “working” means. And that’s why it’s so important that we discuss the different ways value needs to be demonstrated in mHealth.

This mHealth Summit panel will talk about value from the perspectives of the individual, the provider, the payer, the regulator and the researcher. These can be different, but from time to time they converge. Rather than having a number of separate presentations, experts will engage in discussion around a hypothetic but realistic scenario of a mobile health device and what’s needed to provide enough “value” for each to adopt, approve, purchase, share, fund and embrace this as a tool for better health. It is sure to be a lively and informative discussion.

I hope that you’ll be able to join us either in person in Washington, D.C. or electronically to help us shape the dialogue.

Follow the conference discussion through #mHS11, leave a comment below, or follow me on Twitter to join in the conversation.

Converging Ideas at the 2011 mHealth Summit

Sometimes things just come together. We funded the first mHealth Summit because it was interesting and pioneering, and it seemed to have a connection to a few of our Project HealthDesign grants. Then came our involvement with and support of Quantified Self, Open mHealth, the Stanford Mobile Health 2011 conference and the mHealth Evidence meeting. Other programs, like our national program Health Games Research, Games for Health Conference and the Reality Mining meeting that we funded at MIT in 2009, also have strong mHealth associations.

This is more than just coincidence--rather, mHealth focuses on many of the qualities that make Pioneer “pioneering.” mHealth has the potential to radically change the way health and health care is delivered, it is inherently oriented to the individual, and it is an area not yet burdened with the organizational and bureaucratic complexities of traditional health care. mHealth is a place where something radical can happen.

It is therefore particularly gratifying to see that Pioneer will be well-represented at the 2011 mHealth Summit on December 5-7 in Washington, D.C., with grantees featured in sessions on Open mHealth, The Evolution of Gaming and its Effect on Prevention and Wellness, and Wireless Patient Monitoring in Care Facilities: The Future of Wearable mHealth Applications, Devices, and Sensors, and with a  Pioneer-sponsored session, What I Really Need from mHealth: Five Perspectives on Value. This session builds on a discussion that began in August at a Pioneer co-sponsored workshop on mHealth Evidence.

I hope that you’ll be able to join us at the conference, tweet me at @alshar using #mHS11,  and help frame what I’m sure will be a very important discussion.

Time to Bring Designers to the Table: Thought's From Mayo's Transform Symposium

I'm just back from an exciting Mayo's Transform  Symposium. Before saying anything about the conference, I need to mention that being a pedestrian in Rochester, MN may present a significant health danger. I'll have to remember that cars don't stop on the East Coast just because someone is ready to cross a street.

We brought some guests to the meeting both to excite and engage them in helping move our support of Project ECHO forward. I'll let others write about that aspect of the meeting.

Regarding the meeting. I didn't realize that the theme was one about design innovation more than health or healthcare. At first this was off-putting: I wanted to learn about innovation that was going to help change health, not health packaging. I was wrong. I thought that figuring out how to solve a problem was the hard part. Implementing the solution would more or less follow. That's naive. Understanding the way people and the environment react to how solutions are packaged and presented is critical in their acceptance and ultimate success.

This is a good thing and bringing skilled designers to the table is important. We know that understanding where and how a person lives is important in determining what interventions will work but it's equally important to frame them in ways that are consonant with what they think and feel. Seeing the effect of a pediatric MRI designed to look like a pirate ship ride on a child's acceptance of the study or even just a simple reframing of an intervention in a context that resonates makes a world of difference.

It's sad that a collaboration between design and medical professional, with active consumer engagement, is not more common. Designing a solution to the wrong intervention and poorly implementing the right one are wasteful at best. But when things come together well, it can be a beautiful thing.

 

What does mEvidence need to look like?

There is something magical that happens when talking about mHealth. People start believing all of the wonderful things that a phone, together with the right gadget, can do: remind me to take my medicine, monitor my vitals, inform my doctor when something goes wrong, just plain automatically keep me healthy. The last few years have seen a huge growth in cell phone companies, technology companies, governments, application and device developers rushing to deliver product in this space. Just look at the over 500% increase in attendance between the 2009 and 2010 mHealth Summit (with the 2011 meeting promising to be even larger.) Along with the hype and the hope, people are beginning to ask for evidence and to question the value of growing a collection of isolated gadgets and apps.

I’d say that mHealth is somewhere around the asterisk on the “hype cycle” model developed by Gartner.

With that as context, RWJF’s Pioneer Portfolio, together with NIH, NSF, HHS and McKesson Foundation, organized a one day event to begin the process of advancing the Science of mHealth. What does mEvidence need to look like? What are the right methods to accelerate the evaluation of the efficacy of mHealth technologies?   First steps to address this have largely been focusing on attempts to demonstrate value by using a traditional randomized controlled trial, which is often ill suited to testing the interventions that mHealth enables. (It’s interesting to note that on August 14, Paul Meier died. I’d be interested in knowing what he’d be thinking.) When we first started to plan this meeting, I wondered how interested the field would be. After all, this is the drier, academic side of mobile health. I was surprised! We had 106 responses to our call for whitepapers of which we were able to choose 23. The demand for attendance was such that NIH had to arrange for a webcast.  Perhaps looking at transforming the way conduct research [in light of new technologies] is not so dry after all. While the attendees were predominantly US-based, academic, international and corporate interests were represented. The outcome was even more surprising. The group agreed that this was a good and important direction, that we needed to have a collaborative, ongoing and forward looking agenda and that the Science of mHealth was critical to achieving a high enough plateau of productivity. The group will soon issue a statement of direction and commitment, publish the key outcomes of the meeting and develop a longer-term agenda. We are also developing an online community so that we can keep the discussion going. In a couple of weeks the webinar will be available for people who missed it and we will work to keep the groundswell moving.

I’d be remiss not to include the fact that closely aligned is the ideas and ideals of Open mHealth and the work of Pioneer grantees Ida Sim and Deborah Estrin. Not only were they and a number of people in the open mHealth area participants, they organized a second day to help formulate how they were going to develop and move forward.

This is important and people are paying attention. One way that you can help is to respond to the request from the NIH Director’s Common Fund, which is designed to fund transformative research that is of interest to the health community. The Common Fund officials are looking for the community (that is you!) to weigh in on new ideas for funding. Go here to add your comments.

 

Drug Facts Boxes Featured in New York Times

Last week, the New York Times published an op-ed by the Dartmouth Institute’s Steven Woloshin and Lisa M. Schwartz that discussed the critical need for a redesign of something that can empower consumers to make informed decisions about their health care – the information that accompanies prescription drugs. As stated in their own words: “Bombarded with pharmaceutical ads listing what seems like every conceivable side effect, American consumers might think they are already getting too much information. But they — and their doctors — are not getting what arguably matters most: independent, plain-English facts about the medication.”

Prescription medication labels are hard to read, confusing and often leave out crucial information contained in Food and Drug Administration (FDA) review documents. Major side effects or potentially dangerous drug interactions can be hidden to patients on their medication packaging. By giving drug packages a simple makeover and creating a standardized, easy-to-read drug fact box—akin to what’s currently required for nutrition labels—information that is critical to enabling an individual to make the best health care decisions possible will be readily available to all.

Woloshin and Schwartz are leading the charge on the effort to develop these “Prescription Drug Facts Boxes.” Recognizing the opportunity for a simple design change to create better access to information and have a big impact on how people engage with their health care, we have been supporting their efforts since 2008. You can read more about that support here. This idea was simple and powerful enough to be included in the health care reform law.

Policymakers say that an additional three years of study are needed before beginning to implement the facts box. To me, it’s unclear what more they will learn in those three years. I don’t think it’s the lack of an evidence base. Woloshin and Schwartz have done a number of good studies about the efficacy and adding to them should not take three years. I don’t think it’s figuring out how to operationalize the production, a hand book is easily developable. I do think it’s a combination of two important factors: an underrepresented constituency and an overly strong concern for the potential adverse impact of any change.

The underrepresented constituency is the consumer. We are already given information about the intent of the drug and the dangers. The perception is then that the only thing the drug box adds is the ability to make a more informed choice. And that’s not seen as very important. Given that, it’s easy to see why the potential downside of the change needs so much study. If you don’t weight the value very highly, you need to be very sure that there are no “adverse events”.

That’s wrong. We’re being told (and in some cases, compelled) to take more individual responsibility for our health. Being denied access to clear and actionable information is wrong.

 

Time to Evolve Health Care's Gold Standard? Thoughts From 2011 Mobile Health Health Conference

What does "works" mean? Like many things that seem superficially simple, the reality is much deeper. When BJ Fogg chose that as his theme and condition for the recent Mobile Health 2011 conference, he set the bar very high. The good news is that at some level the sessions all had an aspect of things working.

But there was some not so good news as well. Many still see Randomized Controlled Trials (RCT) as the universal and exclusive gold standard for evidence.  For a number of reasons, I think that's unfortunate in the mobile health field. First, to be realistic, the time scale for testing an mHealth intervention needs to be short, often on the order of at most 90 days. That will not provide sufficient evidence for dealing with a long term chronic illness where the time scale is measured in years, not days. I believe that many mobile health treatments that work in the short term will not be sustained long term, unless they change – and change is something that is generally not part of an RCT model.

Second, RCTs generally take a long time and require a fixed methodology, something that doesn't make much sense when dealing in a space where the technology is rapidly changing. By the time you can reach a conclusion, the intervention is often obsolete.

Finally, and perhaps most importantly, by its nature, mobile technology generates a large amount of data that can't be well controlled and is generally discarded (or ignored) in an RCT. Medicine may be the only field that I know of where we discard real life data in favor of clean, laboratory controlled measures. Imagine if the manufactures and maintainers of jet engines relied only on controlled tests and ignored measuring the real world wear and tear on an engine. If that were the case, I would certainly fly a lot less.The United States dropped the monetary gold standard in 1933. Isn't it about time that we at least consider the same thing for medicine?

We recognize this, as do others, and an mHealth Evidence meeting that we are cosponsoring with National Institutes of Health, McKesson, Department of Health and Human Services and the National Science Foundation on August 16 is focused on dealing with this directly. I'm happy to say that the response to the call for white papers for the mHealth Evidence workshop was such that the flyers I brought to Mobile Health 2011 were insufficient to meet the demand, and copies had to be made, not once, but twice.

Luckily, there were enough people with whom this resonates.

You can submit a white paper here on our website. If yours is accepted, you will be invited to attend the mHealth Evidence workshop (travel support will be provided).

Hope to see you there!

 

Examining Innovation Through a Different Lens

Last week I had the opportunity to participate in the International Business Forum’s first Digital Healthcare Innovation Summit, which was held in New York City (Pioneer was a sponsor of the event). The sessions were good and had valuable content, but rather than rehash them, I will focus on those things that I learned about how some leaders in fields outside of health and health care think and work. Unlike many of the meetings we attend, this one was “created for all private equity investors and healthcare professionals to capitalize on the transformation of the healthcare industry.” This focus seemed offer a potentially different approach to technologies that can effectively support healthcare.

And while, superficially, the meeting was quite a bit like many others I’ve attended, there are a number of subtleties that are important and might help us in our work here.

1. Finding a niche in which one can make inroads is more likely to succeed than a full on confrontation. A successful business strategy must be pragmatic.
2. While high tech and wiz-bang solutions may excite, looking at good, stable and proven technologies used innovatively stands a better chance of adoption.
3. Fail early; be prepared to walk away before considering multiple alternatives that might work. Don’t become too committed to either the idea or the constituency that might benefit.
4. Be adaptable; be prepared to grow a small and peripheral kernel of a much bigger project. Major successes can grow from components that begin as ancillary to the main concept.
5. Make sure that the right people are involved.

I think we in Pioneer do a fair amount of thinking along these same lines, but sometimes with what are likely to be different outcomes. For example, with regard to number one above, while we understand the value of finding a safer place to begin innovation, we seem to be more willing to directly confront conventional wisdom. With regard to number two, I think we’re more ready to look to a more unproven and less well vetted technology, with the belief that the technology will mature and become more stable. As for the third point, because the good that could come from success is so compelling, we sometimes are more unwilling to just walk away. While I can cite some major projects (most notably Project Echo and Changemakers) that have come somewhat unexpectedly from others, we don’t tend to look at the small opportunities that may emerge from grander visions. Finally, while we certainly want the right people involved, we’re unlikely to take the innovators and, as a condition of funding, make them turn over the enterprise to another.

Are these changes that we should make? I don’t think so. We are different and our measures of success need to be different as well. However, understanding the world and the way innovation can be supported by early and mid stage investors can help inform us in seeking breakthroughs with the potential to generate significant health and social impact.

 

Time to Accelerate Innovation: Takeaways from this Year's mHealth Summit

I just returned from the mHealth Summit in Washington, D.C. We’ve been sponsors of the event for 2009 and 2010 – both years it’s been held. Last year there were about 400 people who attended. This year there were about 2,500, including prominent guest speakers like Francis Collins, Bill Gates and Aneesh Chopra, among others. There was also a large hall with lots of exhibitors and an extensive poster session. I guess this means that means mobile health is coming of age.

I liked it a lot, but not for the reason you might think. At most of these types of events the presentations tend to expand on the great things that are going on in the field. Here there was a good, healthy dose of skepticism. And there’s a lot to be skeptical about. There are the “show me” skeptics, the ones that ask for evidence that it actually works. There are the regulation skeptics, the ones who know the problems in getting devices approved by the responsible government agencies. There are the “disruptive innovation won’t work here” skeptics. There are the “who will pay for it?” skeptics, not to mention the standards, open source, proprietary, silo, etc. skeptics. It makes my head spin and wonder how we’ll ever get there.

There are two reasons I’m still optimistic. First, in spite of all this, the field is growing and there are big players in the field. Second, many of the issues are starting to be formally addressed at what seems to be appropriate levels. That’s good. There is an area where I think more can be done, and that’s in developing better methods for validation and evidence. There’s still a huge emphasis on the traditional clinical trials model, which sets up a fixed and structured experiment, collects data over a period of time, consolidates and analyzes the data at the end of the trial, and, after a long period of time (maybe five years), reports the outcome.

The field shouldn’t have to wait five years to understand the effects of what by then will be an obsolete intervention. In addition, this is a field where there should be continuous improvement, where tinkerers thrive, where prototypes are the rule. It makes little sense to freeze development when you learn something that will make it better. One solution might be the type of adaptive trial that pharmaceutical companies are investigating. This is one where results at various stages in a trial can effect changes in the trial model. You might change the sample size, the target population, the delivery method, the formulation, etc., based upon analyzing data internal or external to the experiment. Analysis of this model is complex but can be manageable. In the end you should be able to deliver a safer, more effective product sooner.

That’s the germ of one idea for being able to develop an evidence base for mHealth quicker and better than today. These are my thoughts. I’m sure that there are smart and thoughtful people who have others.

TEDMED 2009 = Innovation, Technology & Inspiring Stories

I really liked TEDMED. There was lots of wiz-bang new technology stuff – genetics, organ regeneration, ways to slow the aging process, wearable sensors that can monitor and wirelessly transmit data that traditionally required a person to be in a controlled environment with leads connected to multiple body locations. It’s really exciting to see what may be possible in a few short years. Of course, no one really talks about how long it will take, how real people will be able to use these gadgets and how they’ll be paid for.

 

There are also great stories of human accomplishments – either overcoming tremendous adversities to triumph or innovative and caring ways to help others. Every one of the presentations is worthy of commentary. In addition, it’s amazing to realize the number of incredibly smart people that were there. Not only are they smart but each has accomplished more than one might expect, even given their brain power. And many of them are truly nice and approachable.

 

For me the highlight of the event was Jamie Heywood talking about the Patients Like Me site. The reason for this is less that they are using some pretty impressive analyses but more that you have a platform where ordinary people can record their experiences with their conditions and treatments in a way that contributes to a shared and actionable understanding, without expert clinical intervention. The reality is that right now this helps each participant deal with her or his condition. In addition, it is beginning to yield data that can expand clinical knowledge faster and more broadly than traditional methods. Whether the scientific community can learn how to make use of that data seems to me a question of how open the professionals are to exploring nontraditional sources. I certainly hope they are.

Better Informed Managers of Our Health

Most of what I read and almost all of what I believe is that we, as individuals, must assume primary responsibility for managing our health. I'm also told that I need to become a more informed consumer when making health and health care decisions. As a person who's spent a good part of my career doing research I think that I'm more ready than most to investigate, consider and make informed decision. However, no matter how ready I am, no matter how skilled I am at analytic reasoning, I can not make an informed decision if the information is not available to me.

I know that some of the data is hard to acquire and may be harder to analyze. It is difficult even for hospitals to predict the total cost to the patient of a hospital stay. For drugs used to treat many conditions it can be hard to understand the cost versus the benefit, especially where there are competing choices. The prescription drug situation is further complicated by the fact that there is so much direct to consumer advertising of patent medicines that almost never reveal enough data to make an informed decision.

The perspective article in the recent New England Journal of Medicine discusses the fact that, although the FDA collects and makes available what may be extremely important information about prescription drugs, it does so in a relatively haphazard way. The authors, Lisa M. Schwartz, M.D., and Steven Woloshin, M.D. have developed a format for a "Prescription Drug Facts Box" that has been shown to provide clearer, more actionable information to consumers. We funded an FDA pilot of the Facts Box and, most recently, the FDA's Risk Advisory Committee recommended that the FDA adopt these boxes as the standard for their communications. It seems to me that this is one relatively straight forward way that we can become better informed managers of our health.

Sounds Good; How Do We Get There?

I just read Professor Pentland’s post here and have been learning a bit about what Dr. Richard Katz at George Washington University has been doing in the District of Columbia to use cell phones to assist patients in city clinics to monitor their diabetes. The new round of funding for Project Health Design, focusing on how information about patterns of everyday living can be collected and interpreted, can add to a field that helps empower people to better manage their health.

While all of this is exciting, frankly, I’m a bit frustrated that what seems so intuitively logical and necessary to improve health and health care has not evolved more rapidly. There are lots of independent researchers doing independent work, cell phone manufacturers seem engaged and some consumer-oriented businesses are selling product. But it doesn’t seem to me that a “field” is emerging. Part of the reason for this may be that the government has yet to acknowledge that this is field that is worth a major investment. The traditional structures at NIH are such that this field isn’t a natural “fit” and that there isn’t enough “evidence.” Of course, part of the reason there isn’t an evidence base is that funding for its development has been lacking. Private funders – corporate and philanthropic – tend to operate independently, making the development of an evidence base difficult.

We are at a point in time when there is unprecedented opportunity. Health reform and the economic stimulus funding can help make tremendous inroads here. The only question is how to align the need, the technology, the science and the funding. I’d like to hear how others think we can bring it all together.

When Simple Works

Good health information ideas that work don’t have to be complex, use lots of technology and be hard for the user to understand. That’s the way I read the article “Communicating Drug Benefits and Harms With a Drug Facts Box: Two Randomized Trials” by Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS; and H. Gilbert Welch, MD, MPH that appeared in the newest issue of the Annals of Internal Medicine. If you don’t want to read the whole thing, USA Today ran a good summary of the study outcomes.

 

The idea is fairly simple: replace the brief summary page that accompanies print advertisements for prescription drugs with a “drug facts box,” a table that quantifies outcomes with and without the drug. The idea is similar to the nutrition information that is standard on foods sold in supermarkets. The article discussed two trials, a symptom drug box trial using direct to-consumer ads for a histamine-2 blocker and a proton-pump inhibitor to treat heartburn, and a prevention drug box trial using direct-to-consumer ads for a statin and clopidogrel to prevent cardiovascular events. Since the pharmaceutical industry spent more than $5 billion on these ads in 2007 – more than twice the total U.S. Food and Drug Administration (FDA) budget – finding a way to help inform consumers is important.

 

The results were impressive. In the symptom drug box trial, 70% of the drug box group and 8% of the control group correctly identified the PPI as being “a lot more effective” than the histamine-2 blocker (P 0.001). In the prevention drug box trial, 72% of the drug box group and 9% of the control group correctly quantified the benefit of the statin. (See left for a sample).

Last August Pioneer helped fund a collaboration between this research team and the FDA in the development of 10 prototype boxes. Unfortunately, right now the FDA seems absorbed with, once again, studying the “best” way to work. Sometimes striving for perfection impedes actions that can have a positive effect right now. This might be one of those times.

Amplyifying how my body talks to me (and others)

It doesn’t take much insight to know that the current method of delivering (and paying for) health is broken and not sustainable. Making changes at the margins won’t work. Aside from current (and obvious) inefficiencies, we have a population that’s living longer, has more medical conditions and more methods for treating them. Even if you believe your personal health care support is doing OK, you have to know that there’s a crisis in the future. If you believe we’re already in a crisis, you know we’re heading for a catastrophe.

 

There is a school of thought that crises have a way of solving themselves. There’s a great story about how at the start of the 20th century, with the growth of the telephone, there was a fear that the number of switchboard operators needed for manual switching systems would soon exceed supply, and that the problem was solved (just in time) by the invention of automated switching systems. This story was repeated as recently as 1998 in a letter to the NY Times. Unfortunately, this story is not true. The first automatic switch was invented in 1889 by Almon B. Strowger who developed it because he believed the operator was deliberately routing calls to his competition. In fact, as late as 1920 Bell in Atlanta continued to use operators and only changed when there was an operator strike.

Recognizing, therefore, that most crises are not self-resolving, and at our request, the Center for Future Health at the University of Rochester convened a diverse group of thought leaders interested in real-time personalized health monitoring. They came to discuss how people might benefit from personalized self-care systems, how such systems might enable people to take more responsibility for their own health and what RWJF might do to advance the field. What we learned is that there are amazing things taking shape that hold the promise of technologies that are both useful (in terms of their ability to improve our health) and unobtrusive, that there are lots of single point experiments and that there are major obstacles to coherent development. The challenge remains finding activities that can be transformational in accelerating the field while avoiding, or at least mitigating, some of the costly dead ends.

How am I feeling...next Wednesday?

What if you knew what was going to happen in the next two days? I would bet on the lottery number that I knew was coming up and, perhaps, avoid some of the mistakes I almost certainly would make.

 

This might sound a bit like science fiction but researchers at the Center for Future Health at the University of Rochester are beginning to demonstrate that people with heart disease will be able to know their health status future and be able to take action to change it. Under that scenario, I would be able to take action on Thursday so that I’d be able to dance at my daughter’s wedding Saturday night.

 

This is not as far fetched as it might sound. Engineers have been using sensors to monitor the “health” of machines so that they can predict and avoid failures, and they have teamed with medical professionals and computer scientists to see if they can develop comfortably wearable devices that can measure and interpret signals that can define a health index that adapts as it learns more about the individual who is wearing it. Such a system can translate those learnings into actions that can help the end user get better or alert others that other actions need to be taken.

 

Early results are promising. Working with a small sample of patients and healthy people, they’ve found that they can use sensors that are easy to wear, collect appropriate data and can transfer readings to a smart phone. They can distinguish between healthy and sick people and detect changes that seem to presage future events. They’ve even been able to build a wearable prototype as a proof of concept. The patients (from varied backgrounds) that have volunteered to be part of this project are all engaged and enthusiastic.

 

However, there are a huge number of questions that need answers. Data are being collected in a way that they haven’t before so interpretation is not yet validated or refined. It’s still unclear what needs to be collected and how good a job one can do in predicting future events. Does the methodology generalize to other conditions? How will the health profession be engaged and participate? There are certainly more questions than answers at this point.

 

But we have learned that the field of machine monitoring and prediction can teach us something about health management. And maybe, someday, I’ll discovery the winning lottery number a day before it’s picked.

A Horse, a Mule...or Neither?

I’m confused! Last week I went to see Michael Moore’s Sicko (read Susan Brink’s excellent Los Angeles Times article) and came away thinking that he’s got the solution to the U.S. healthcare problem. It’s a single payer universal health care system. Then I read Vijay Goel’s response to my blog posting and learned that it’s a collection (from the patients) and efficiency (from third party payers) problem that direct payments to providers would solve. The week before I was out to dinner with a friend who was able to retire early and tried and failed to find an HSA that would include his doctors and medicines. Finally, I went out to dinner with a physician friend who’s now in her own boutique practice. She said that she’s finally giving the kind of care that she’s wanted to provide: immediate access, enough time to spend with and for her patients, enough free time. Before this she was looking forward to getting out of medical practice – she now says she never plans to stop.

I feel a bit like the rabbi in Fiddler on the Roof who states that both parties, one claiming that the animal was a horse, the other a mule, are both right. When told that that was impossible, he said that that’s right too. The fact is that we’ve created a very complex system of health care delivery that can’t/shouldn’t be sustained. We don’t yet have consensus for a solution, if one exists, or a collection of solutions that might coexist. Every possible solution has consequences that are potentially catastrophic but in espousing a particular direction the rules seem to be that consequences need to be ignored until after the argument has been decided.

It’s particularly American to think that some hero riding a big white horse will come to our aid and find the perfect solution just in the nick of time. I don’t think that’s likely to happen.

Rapid Innovation in the Health Care Payment System?

The McKinsey Quarterly recently released an article (registration required to view) entitled "Overhauling the U.S. Health Care Payment System." Since their tag line read: "During the next five years, rapid innovation may restructure the value chain of health care payments and change the sector's balance of power," and since in Pioneer we focus on rapid and disruptive innovation, I was intrigued.

In the article, the authors repeat what has been a familiar refrain: the U.S. health care payment system is hugely inefficient and ripe for transformation. They state that the system processes $1.9 trillion a year, that the system consumes about 15 percent of that as compared to about 2 percent for retail transactions and that consumer-driven health care plans will likely drive up this percentage (because of non-payments). One of their suggestions is that intermediating consumer-to-provider payments through credit lines, debit cards with financial institutions potentially becoming the center of this process will introduce efficiencies and savings. Frankly, I'm a little tired of the comparisons between retail commerce and the funding of health care.

I think that, while there's a lot in the article that is worth considering, there are also some significant problems with both the data and the focus. Maybe it's me, because I taught statistics for many years, but I become suspicious when numbers and focus don't jibe. For example, the $1.9 trillion includes, for some undefined reasons, $140 billion from "taxpayers" (their term) to public health and research and $100 billion from foundations. I know that's under $250 billion, but a quarter of a trillion here or there does add up to some real money.

In reality, there seem to be two (perhaps three) distinct cash flows at work. The first is direct payments from consumers to providers; this totals $250 billion and, according to McKinsey, incurs a loss of $40-$60 billion. The second is payments through a payer; this amounts to $1,260 billion with costs of $150 billion. Using these figures, the direct payment overhead is 16-17 percent. For the payment stream that moves through payers, the overhead is 10.5 percent.

In addition, the figures for payments through a payer include a mix of government and private payers with no indication of the difference. I would like to have seen some distinction made here, especially since taxpayers account for almost 60% of the funds handled by payers.

McKinsey does provide some valuable insights about ways of addressing the multitude of problems, but by not differentiating among payment sources, and by not clearly matching solutions with problems, I'm afraid this report will suffer the same fate as previous insightful studies; they allow the authors and some readers to feel a bit superior as nothing much happens.

Thoughts from the CDC's Future of Health Technology Symposium

Last Thursday’s meeting at the CDC was as diverse as it was brief. Its coverage ranged from large(robots) and small (wearable monitors) devices currently in the field to leading edge research that may someday have impact. It would be impossible for a short blog entry to do it justice. Instead, I want to focus on one presenter who to me, at first, seemed almost comical, but left me with thoughts that I continue to reflect upon.

Kevin Warwick is Professor of Cybernetics at the University of Reading, England. In 1998 he had an RFID chip implanted in his forearm. This experiment allowed a computer to monitor him as he moved around and allowed him to operate doors, lights, heaters and other computers without lifting a finger. More recently (2002) Dr. Warwick had a microelectrode array fired into the median nerve fibers below the elbow joint and later a similar operation was performed on his wife, potentially making them the first couple to “electronically” demonstrably communicate telepathically. Part of his presentation showed clips of two people. One had Parkinson’s and his tremors were removed as a result of a deep brain probe. The other had a sophisticated artificial arm that served as a replacement to one that was lost to cancer.

There was certainly something macabre about what Dr. Warwick has done to himself and his wife, and indeed there has been criticism about his methods and the real value of these experiments.  For me, however, these experiments highlight a collection of ethical questions that need to be addressed as newer technologies enable human changes that were not possible in the past. We are quite comfortable with a drug that lowers cholesterol and lets one live longer and healthier. I (and I’d say most people) are sympathetic and accepting of an implant that would allow a paralyzed person to walk or an artificial limb to replace one lost to disease. If it would be OK to replace an arm lost to an injury with a new computerized arm that is stronger and easier to control than the original, would it then be OK to remove my right arm and replace it with a new one so that I could become the best pitcher in the major leagues? How about if it would just help me with my golf game?

How will these decisions be made in the future? Who will make them? Who will fund the new technologies?  As a society, are we willing to support going as far as technology will take us?

These are questions we are facing right now. Last week it was announced that a baby who was born at 21 weeks, six days of gestation is leaving the hospital after spending four months in a neonatal intensive care unit. The American Association of Pediatrics states that babies born at this gestational age and weight weight are not considered viable.  While the physician in this case tried hard to position this birth as an unique situation, it is unlikely to remain so for long. At the other end of life, my mother and mother-in-law are regularly scheduled for tests (paid for by Medicare) where the results are, or should be, irrelevant – these women are probably not healthy enough to tolerate any treatment for a condition the tests would reveal.

Technology will continue to advance regardless of how prepared we are to respond to the social, ethical, economic and human consequences. It is up to all of us to formulate, address and most of all answer the questions this advancing technology raises, in parallel with the evolving science.

Informing the Use of Technology's Potential

The reality of the proactive health system I described a few days ago is, of course, complex. What technologists envision as simple solutions may not be consistent with the realities of how health support is delivered by professionals. And often, neither group understands the realities of being a patient.

For me that is one of the significant learnings to come out of a workshop that the Center for Future Health conducted for us last year. They brought together technologists, health professionals, patients and their families to try and understand and begin to solve problems.

The technique used was to place each different constituency—patients, technologists, health professionals—in a “fish bowl,” with others observing, to discuss a topic from each perspective. Two outcomes especially surprised me:

The Future of Aging

Developments in health and health care are allowing us to live longer—and yet, as our senior population doubles over the next two decades, how will the existing health delivery system meet the demand for services this aging population is already creating? My father-in-law recently had to wait over an hour at a “minute clinic” in Florida just to be told to go to an emergency room! What will happen in 2011, when the first of the baby boomers turn 65, and beyond?

It is uniquely American to believe that we can develop and apply technology innovation to this looming problem. The vision of technologies that monitor our bodies and environment, letting us (and authorized others) know what changes have occurred and what actions may need to be taken, is intriguing.

To explore this vision, we’ve worked with CAST (The Center for Aging Services Technologies) and we helped fund a video, Imagine - the Future of Aging, that beautifully describes it. This video is the winner of the Telly Award which “honor(s) the very best local, regional, and cable television commercials and programs, as well as the finest video and film productions.”  Take a look and see what you think.

Another group that we’ve worked closely with is the Center for Future Health at the University of Rochester.  This group was founded in 1998 to give patients, caregivers, and physicians better health status information through personal health technology. They are working towards a “proactive health system” that will put health care technologies into everyday lives and off-load formal institutions when appropriate. It is a system of sensors and information technology that alerts individuals when their health status trends away from normal, and helps them return to health.

In my next post I'll describe what we've learned as the Center for Future Health, working with Pioneer, has further explored the proactive health system concept.